# K020069: Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Midas Rex
- Decided: Mar 18, 2002 after 68 days
- Product code: HBB (Motor, Drill, Pneumatic)
- Device class: 2
- Regulation: 21 CFR 882.4370
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
43 later devices descend from it; 11 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Midas Rex Classic: named in the summary without a submission number
- (no number) Midas Rex III Instrumentation System: named in the summary without a submission number
- (no number) Mednext 1000 Bone Dissecting System: named in the summary without a submission number

## Most influential descendants
- K090112: Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700 (2009), 20 descendants of its own
- K072315: Midas Rex Curved Bur (2007), 13 descendants of its own
- K170312: IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools (2017), 11 descendants of its own
- K163182: Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories (2017), 10 descendants of its own
- K160713: Stealth-Midas System (2016), 9 descendants of its own

## Recalls of this device
- Apr 8, 2016 · Class II · Z-1602-2016: Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
- Oct 21, 2015 · Class II · Z-0321-2016: The wire pass hole is not present on the tools.
- Nov 30, 2009 · Not classified · Z-0546-2010: Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use.
- May 30, 2008 · Not classified · Z-2156-2008: Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. This may lead to reduced cutting performance, inability to perform desired dissection, increased risk of ov
- Sep 1, 2005 · Not classified · Z-1574-05: Potential compromise of sterile packaging for disposable dissecting tools.
- Jun 29, 2005 · Not classified · Z-1067-05: Complaints of finger control component breaking off and falling into open surgical wound.
- Nov 11, 2004 · Not classified · Z-0278-05: Softer hose increases the propensity for outer exhaust hose to kink or become occluded as a result of clamping. Complaints of hose rupture/burst have been reported.
- Nov 3, 2004 · Not classified · Z-0213-05: Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke).
- Nov 11, 2002 · Not classified · Z-0419-03: Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case.

## Indications for use
The Medtronic Midas Rex Legend System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

Source page: https://510kreport.com/device/K020069
Methodology: https://510kreport.com/methodology